Stress Urinary Incontinence

Pipeline Programs

Companies

Clinical Trials

3 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Cell Therapy

1100%

+ 46 programs with unclassified modality

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Prevail TherapeuticsNY - New York

3 programs

duloxetine HClPhase 41 trial

DuloxetinePhase 31 trial

Active Trials

NCT00190645Completed600Est. May 2006

NCT00190632Completed600Est. Apr 2006

NCT00190905Completed4,000Est. Jul 2005

AstellasChina - Shenyang

1 program

solifenacinPhase 41 trial

Active Trials

NCT01505439Completed311Est. Jun 2014

Cook MyoSitePA - Pittsburgh

5 programs

AMDC-USRPhase 31 trial

Autologous Muscle Derived CellsPhase 21 trial

autologous muscle cell injectionPhase 21 trial

iltamiocelN/ACell Therapy1 trial

Active Trials

NCT06743620Enrolling By Invitation96Est. Apr 2032

NCT01008943Completed16Est. Sep 2012

NCT00847535Completed66Est. Nov 2011

+2 more trials

Taiho PharmaJapan - Tokyo

3 programs

TAS-303Phase 21 trial

TAS-303 18 mg/dayPhase 21 trial

TAS-303 18mg single-dosePhase 11 trial

Active Trials

NCT02562807Completed16Est. Mar 2016

NCT02906683Completed337Est. Apr 2018

NCT04512053Completed231Est. Dec 2021

Levee MedicalNC - Durham

2 programs

Voro Urologic ScaffoldPhase 21 trial

ControlN/A1 trial

Active Trials

NCT06351579Completed30Est. Jul 2025

NCT06275945Active Not Recruiting40Est. Oct 2026

InnovacellAustria - Innsbruck

1 program

Transurethral intrasphincteric autologous myoblast implantationPhase 1/2

Innovacell BiotechnologieAustria - Innsbruck

1 program

Transurethral intrasphincteric autologous myoblast implantationPhase 1/21 trial

Active Trials

NCT01355133Completed40Est. Feb 2011

BiocorpFrance - Issoire

2 programs

Inko RS DevicePhase 11 trial

Neurotech Vital CompactN/A1 trial

Active Trials

NCT02423005Completed180Est. Apr 2017

NCT01472068Completed21Est. Oct 2012

AbbVieNORTH CHICAGO, IL

1 program

onabotulinumtoxin APhase 11 trial

Active Trials

NCT04984317Suspended20Est. Aug 2027

Boston ScientificCA - Valencia

6 programs

AMS 800 Artificial Urinary SphincterN/A1 trial

American Medical SystemsN/A1 trial

Prefyx PPS™ SystemN/A1 trial

RP SlingN/A1 trial

Solyx Single Incision Sling SystemN/A1 trial

+1 more programs

Active Trials

NCT04088331Completed145Est. May 2024

NCT00998790Completed114Est. Dec 2012

NCT00688298Completed100Est. Mar 2008

+3 more trials

ColoplastAustralia - Mulgrave

6 programs

Altis Single Incision SlingN/A1 trial

Altis Single Incision Sling SystemN/A1 trial

Altis® Single Incision Sling SystemN/A1 trial

Coloplast Virtue® Male SlingN/A1 trial

Virtue® Male Incontinence SlingN/A1 trial

+1 more programs

Active Trials

NCT02348112Completed416Est. Sep 2021

NCT02049840Completed153Est. Jul 2021

NCT01272284Completed113Est. Jan 2014

+3 more trials

Boehringer IngelheimINGELHEIM, Germany

3 programs

DuloxetinePHASE_3

duloxetine HClPHASE_4

Human BioSciencesWV - Martinsburg

2 programs

Solyx Single-incision SlingN/A1 trial

Vaginal pessaryN/A1 trial

Active Trials

NCT06480227Recruiting358Est. Dec 2030

NCT05611970Terminated7Est. Apr 2024

Affluent MedicalFrance - AIX-EN-PROVENCE

1 program

Artificial Urinary Sphincter implantationN/A1 trial

Active Trials

NCT04827199Not Yet Recruiting70Est. Dec 2034

Caldera MedicalCA - Westlake Village

1 program

Desara® One Single Incision SlingN/A1 trial

Active Trials

NCT04772131Recruiting300Est. Nov 2026

Thea PharmaMA - Waltham

1 program

Dorsal genital nerve stimulationN/A1 trial

Active Trials

NCT05804552CompletedEst. Mar 2023

VerathonBC - Burnaby

1 program

LyretteN/A1 trial

Active Trials

NCT01455779Unknown54Est. Jul 2015

Innovation PharmaceuticalsMA - Wakefield

1 program

Magnetic stimulationN/A1 trial

Active Trials

NCT05952258Enrolling By Invitation158Est. Jul 2028

UNION therapeuticsDenmark - Hellerup

1 program

PFMT with deviceN/A1 trial

Active Trials

NCT05115864Completed500Est. Nov 2024

UromedicaMN - Plymouth

1 program

ProACT Adjustable Continence Therapy for MenN/A1 trial

Active Trials

NCT03767595Recruiting145Est. Sep 2030

Oregon TherapeuticsFrance - Paris

1 program

Retropubic midurethral slingN/A1 trial

Active Trials

NCT03942549Unknown20Est. Dec 2020

ElidahCT - Newtown

1 program

Transcutaneous electrical stimulationN/A1 trial

Active Trials

NCT03782116Completed87Est. Mar 2019

VersamebSwitzerland - Basel

1 program

VMB-100PHASE_21 trial

Active Trials

NCT06247241Withdrawn0Est. Apr 2029

Johnson & JohnsonNEW BRUNSWICK, NJ

1 program

TVT-OPHASE_41 trial

Active Trials

NCT01095159Completed124Est. Dec 2013

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

Astellassolifenacin

Johnson & JohnsonTVT-O

Prevail Therapeuticsduloxetine HCl

Cook MyoSiteAMDC-USR

Prevail TherapeuticsDuloxetine

VersamebVMB-100

Levee MedicalVoro Urologic Scaffold

Taiho PharmaTAS-303 18 mg/day

Taiho PharmaTAS-303

Cook MyoSiteAutologous Muscle Derived Cells

Cook MyoSiteautologous muscle cell injection

Innovacell BiotechnologieTransurethral intrasphincteric autologous myoblast implantation

AbbVieonabotulinumtoxin A

Showing 15 of 43 trials with date data

Clinical Trials (43)

Total enrollment: 10,334 patients across 43 trials

NCT01505439 Astellassolifenacin

A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Start: Jun 2011Est. completion: Jun 2014311 patients

Phase 4Completed

NCT01095159 Johnson & JohnsonTVT-O

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Start: Feb 2009Est. completion: Dec 2013124 patients

Phase 4Completed

NCT00190905 Prevail Therapeuticsduloxetine HCl

Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

Start: Feb 2004Est. completion: Jul 20054,000 patients

Phase 4Completed

NCT03997318 Cook MyoSiteAMDC-USR

Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)

Start: Jun 2025Est. completion: Jun 20270

Phase 3Withdrawn

NCT03104517 Cook MyoSiteAMDC-USR

Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Start: Apr 2019Est. completion: Sep 202796 patients

Phase 3Active Not Recruiting

NCT00190632 Prevail TherapeuticsDuloxetine

To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Start: Mar 2001Est. completion: Apr 2006600 patients

Phase 3Completed

NCT00190645 Prevail TherapeuticsDuloxetine

To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Start: Feb 2001Est. completion: May 2006600 patients

Phase 3Completed

NCT06247241 VersamebVMB-100

A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

Start: Sep 2025Est. completion: Apr 20290

Phase 2Withdrawn

NCT06275945 Levee MedicalVoro Urologic Scaffold

Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

Start: Apr 2023Est. completion: Oct 202640 patients

Phase 2Active Not Recruiting

NCT04512053 Taiho PharmaTAS-303 18 mg/day

A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Start: Sep 2020Est. completion: Dec 2021231 patients

Phase 2Completed

NCT02906683 Taiho PharmaTAS-303

Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

Start: Oct 2016Est. completion: Apr 2018337 patients

Phase 2Completed

NCT01008943 Cook MyoSiteAutologous Muscle Derived Cells

Autologous Cell Therapy for Female Stress Urinary Incontinence

Start: Jun 2010Est. completion: Sep 201216 patients

Phase 2Completed

NCT00847535 Cook MyoSiteautologous muscle cell injection

An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

Start: Oct 2008Est. completion: Nov 201166 patients

Phase 2Completed

NCT01355133 Innovacell BiotechnologieTransurethral intrasphincteric autologous myoblast implantation

Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence

Start: Aug 2009Est. completion: Feb 201140 patients

Phase 1/2Completed

NCT04984317 AbbVieonabotulinumtoxin A

Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Start: Feb 2022Est. completion: Aug 202720 patients

Phase 1Suspended

NCT02562807 Taiho PharmaTAS-303 18mg single-dose

A Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Start: Oct 2015Est. completion: Mar 201616 patients

Phase 1Completed

NCT01472068 BiocorpInko RS Device

A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence

Start: Dec 2011Est. completion: Oct 201221 patients

Phase 1Completed

NCT06743620 Cook MyoSiteiltamiocel

Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Start: Apr 2025Est. completion: Apr 203296 patients

N/AEnrolling By Invitation

NCT06480227 Human BioSciencesSolyx Single-incision Sling

Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Start: Aug 2024Est. completion: Dec 2030358 patients

N/ARecruiting

NCT05952258 Innovation PharmaceuticalsMagnetic stimulation

Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Start: Sep 2023Est. completion: Jul 2028158 patients

N/AEnrolling By Invitation

NCT06351579 Levee MedicalControl

Data Collection Post Radical Prostatectomy

Start: Mar 2023Est. completion: Jul 202530 patients

N/ACompleted

NCT05804552 Thea PharmaDorsal genital nerve stimulation

The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Start: Mar 2023Est. completion: Mar 2023

N/ACompleted

NCT05611970 Human BioSciencesVaginal pessary

Pippa Pessary Study (Clinical Trial)

Start: Feb 2023Est. completion: Apr 20247 patients

N/ATerminated

NCT04827199 Affluent MedicalArtificial Urinary Sphincter implantation

Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)

Start: Dec 2022Est. completion: Dec 203470 patients

N/ANot Yet Recruiting

NCT05115864 UNION therapeuticsPFMT with device

Comparison Between Home-based Wearable Device and Supervised PFMT on SUI/MUI

Start: Mar 2022Est. completion: Nov 2024500 patients

N/ACompleted

NCT04772131 Caldera MedicalDesara® One Single Incision Sling

Desara ® One Single Incision Sling 522 Study

Start: Nov 2021Est. completion: Nov 2026300 patients

N/ARecruiting

NCT04586166 Boston ScientificRP Sling

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

Start: Dec 2020Est. completion: Dec 2032180 patients

N/AActive Not Recruiting

NCT04088331 Boston ScientificAMS 800 Artificial Urinary Sphincter

Artificial Urinary Sphincter Clinical Outcomes

Start: Oct 2019Est. completion: May 2024145 patients

N/ACompleted

NCT03942549 Oregon TherapeuticsRetropubic midurethral sling

Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

Start: May 2019Est. completion: Dec 202020 patients

N/AUnknown

NCT03767595 UromedicaProACT Adjustable Continence Therapy for Men

ProACT Post-Approval Study

Start: Feb 2019Est. completion: Sep 2030145 patients

N/ARecruiting

NCT03782116 ElidahTranscutaneous electrical stimulation

Stress Incontinence Trial With Elitone Device

Start: Sep 2018Est. completion: Mar 201987 patients

N/ACompleted

NCT02423005 BiocorpNeurotech Vital Compact

Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US

Start: Apr 2015Est. completion: Apr 2017180 patients

N/ACompleted

NCT02348112 ColoplastAltis Single Incision Sling

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Start: Jan 2015Est. completion: Sep 2021416 patients

N/ACompleted

NCT02049840 ColoplastAltis Single Incision Sling System

The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

Start: Dec 2013Est. completion: Jul 2021153 patients

N/ACompleted

NCT01784588 Boston ScientificSolyx Single Incision Sling System

Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

Start: Jun 2013Est. completion: Jan 2018281 patients

N/ACompleted

NCT01608789 ColoplastVirtue® Male Sling

Virtue® European Study

Start: Aug 2012Est. completion: Jun 2018123 patients

N/ACompleted

NCT01455779 VerathonLyrette

Lyrette: Renewing Continence Objective and Subjective Efficacy Study

Start: Sep 2011Est. completion: Jul 201554 patients

N/AUnknown

NCT01272284 ColoplastAltis® Single Incision Sling System

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

Start: Dec 2010Est. completion: Jan 2014113 patients

N/ACompleted

NCT01170728 ColoplastColoplast Virtue® Male Sling

Virtue® Male Sling Fixation Study

Start: Jul 2010Est. completion: Jun 201444 patients

N/ATerminated

NCT00856778 ColoplastVirtue® Male Incontinence Sling

Virtue® Male Incontinence Sling Study

Start: Jan 2009Est. completion: Jan 201198 patients

N/ACompleted

NCT00998790 Boston ScientificAmerican Medical Systems

A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

Start: Jan 2007Est. completion: Dec 2012114 patients

N/ACompleted

NCT00688181 Boston ScientificThe Prefyx PPS™ Pre-pubic Sling System

The Prefyx PPS™ System eRegistry

Start: Dec 2006Est. completion: Apr 200944 patients

N/ACompleted

NCT00688298 Boston ScientificPrefyx PPS™ System

Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence

Start: May 2004Est. completion: Mar 2008100 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals

3 actively recruiting trials targeting 10,334 patients

24 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.